Orchard Therapeutics, MolMed Extend Gene Therapy Mfg. Pact

Orchard Therapeutics and MolMed S.p.A have extended their collaboration initiated in April 2018, through June 2025. MolMed will continue to support activities related to the development and manufacture of vectors and drug products for several of Orchard’s investigational ex vivo hematopoietic stem cell (HSC) gene therapies, including OTL-200 for metachromatic leukodystrophy (MLD), OTL-103 for Wiskott Aldrich syndrome (WAS), and OTL-203 for mucopolysaccharidosis type I (MPS-I).

MolMed is the first company to have obtained good manufacturing practice (GMP) authorization for the gene and cell therapy markets in Europe and is the manufacturer for Strimvelis, Orchard’s ex vivo HSC gene therapy for severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID) and the first such treatment approved by the European Medicines Agency (EMA).

OTL-200 for MLD is currently under review by the EMA with a decision expected later this year.